510(k) K884827

KODAK DENTAL BARRIER PAC by Eastman Kodak Company — Product Code IWZ

K884827 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "KODAK DENTAL BARRIER PAC". The FDA issued a decision of Substantially Equivalent on January 30, 1989. The device falls under product code IWZ (Film, Radiographic), a Class I device regulated under 21 CFR 892.1840. Eastman Kodak Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1989
Date Received
November 18, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Film, Radiographic
Device Class
Class I
Regulation Number
892.1840
Review Panel
RA
Submission Type